Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

Xijing Hospital of Digestive Diseases

Status and phase: Completed; Phase 4

Conditions: Gastritis; Peptic Ulcer; Dyspepsia

Treatments: Drug: Clostridium butyricum capsule; Drug: Bacillus clotting; Drug: clarithromycin; Drug: esomeprazole; Drug: amoxicillin; Drug: Bismuth

Study type: Interventional

Funder types: Other

Identifiers

NCT05237115

K111111

Details and patient eligibility

About

This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Full description

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Enrollment: 600 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18~75,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
3. Patients are willing to receive eradication treatment.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion criteria

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. contraindications or allergies to research drugs.
3. Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
6. Pregnant or lactating women.
7. Underwent upper gastrointestinal Surgery.
8. highly atypical hyperplasia, have symptom of dysphagia.
9. Evidence of bleeding or iron eficiency anemia.
10. A history of malignancy.
11. Drug or alcohol abuse history in the past 1 year.
12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
13. a person with a mental disorder
14. Enrolled in other clinical trials in the past 3 months.
15. Refusal to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Clostridium butyricum group

Experimental group

Description:

given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Treatment:

Drug: clarithromycin

Drug: Clostridium butyricum capsule

Drug: amoxicillin

Drug: esomeprazole

Bacillus clotting group

Experimental group

Description:

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Treatment:

Drug: clarithromycin

Drug: Bacillus clotting

Drug: amoxicillin

Drug: esomeprazole

bismuth quadruple therapy

Active Comparator group

Description:

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Treatment:

Drug: clarithromycin

Drug: Bismuth

Drug: amoxicillin

Drug: esomeprazole